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628446

Bentley Laboratories LLC — FEI 2244819

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 17, 2009
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Edison, NJ (United States)

Facility

Other inspections at this facility

  • 1177681 (VAI Wed Aug 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015851 (VAI Fri Jun 09 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 891860 (VAI Tue Sep 02 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 760764 (VAI Mon Jan 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
122221 CFR 211.67(b)(4)Cleaning SOPs/equipment identification
145421 CFR 211.115(a)Reprocessing procedures not written or followed
202621 CFR 211.192Quality control unit review of records
202821 CFR 211.192Extent of discrepancy, failure investigations
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
440221 CFR 211.192Written record of investigation incomplete